FDA recall record

Western Drug Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL recall — FDA D-0457-2016

Lack of Assurance of Sterility

Class IIclassification
D-0457-2016official record ID
Dec 9, 2015report date

Recall record at a glance

Official recordD-0457-2016
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmWestern Drug
Report dateDec 9, 2015
Recall initiation dateOct 19, 2015
Quantity75 containers
LocationSpringerville, AZ, United States

Official product description

Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Why the product was recalled

Lack of Assurance of Sterility

Distribution information

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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